Biophytis has secured approval from the Federal Agency for Medicines and Health Products (FAMHP) to carry out the Phase llb interventional study of Sarconeos (BIO101) for the treatment of sarcopenia in Belgium.
The approval has allowed Biophytis to begin the SARA-INT Phase llb study in three clinical centres in Belgium including the University Hospital of Liège, which is a part of the SARA-OBS observational study.
The planned trial will enrol 334 patients and will be conducted across 20 clinical centres in Belgium, France, Italy, and the US.
The three-arm interventional, randomised, double-blind placebo-controlled trial seeks to evaluate the safety and efficacy of Sarconeos (BIO101) in doses of 175mg and 350mg in patients aged 65 years and over who are suffering from sarcopenia and are at-risk of mobility disability.
During the trial, Sarconeos (BIO101) will be orally administered to the patients over a period of six months.
Biophytis CEO Stanislas Veillet said: “After receiving approval from the Food and Drug Administration (FDA) at the end of October, we are pleased to receive the approval from the FAMHP to initiate the SARA-INT interventional study in Belgium.
"This is another important milestone in the clinical development of our drug candidate Sarconeos in Europe.
"SARA-INT is the first clinical study to demonstrate the efficacy of a drug candidate on mobility in sarcopenic patients."
Biophytis aims to receive regulatory approvals in France and in Italy for the SARA-INT Phase llb study, as well as include the first patients of the trial in the US and in Europe.
The patients are expected to be hired from the group of sarcopenic patients who participate in the SARA-OBS study.